Add-on to Micamlo BP Trial
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT01975246
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan+amlodipine+HCTZ Telmisartan + amlodipine telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet Telmisartan+amlodipine Telmisartan + amlodipine telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet Telmisartan+amlodipine Placebo telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet Telmisartan+amlodipine+HCTZ hydrochlorothiazide telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
- Primary Outcome Measures
Name Time Method Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period. baseline and week 8 Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period. baseline and week 8 Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period baseline and week 8 Patients with trough seated DBP =\>90 mmHg or trough seated SBP \>=140 mmHg at baseline were analysed.
Trial Locations
- Locations (30)
1348.1.015 Boehringer Ingelheim Investigational Site
🇯🇵Atsubetsu-ku,Sapporo,Hokkaido, Japan
1348.1.006 Boehringer Ingelheim Investigational Site
🇯🇵Bunkyo-ku, Tokyo, Japan
1348.1.002 Boehringer Ingelheim Investigational Site
🇯🇵Chiyoda-ku, Tokyo, Japan
1348.1.005 Boehringer Ingelheim Investigational Site
🇯🇵Chiyoda-ku, Tokyo, Japan
1348.1.031 Boehringer Ingelheim Investigational Site
🇯🇵Chiyoda-ku, Tokyo, Japan
1348.1.030 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Tokyo, Japan
1348.1.033 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku, Tokyo, Japan
1348.1.016 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku,Sapporo,Hokkaido, Japan
1348.1.021 Boehringer Ingelheim Investigational Site
🇯🇵Chuo-ku,Tokyo, Japan
1348.1.024 Boehringer Ingelheim Investigational Site
🇯🇵Itabashi-ku, Tokyo, Japan
Scroll for more (20 remaining)1348.1.015 Boehringer Ingelheim Investigational Site🇯🇵Atsubetsu-ku,Sapporo,Hokkaido, Japan